Dispenser

ABSTRACT

A dispensing apparatus for dispensing a unit dose of a pharmaceutical substance, in particular one for intranasal administration, is disclosed. The unit dose is contained in a cylinder which is moved relative to a piston to expel the contents thereof through a passage in the piston and out of a nozzle opening. The dispensing apparatus includes a case with a base part and a cover.

This application is filed pursuant to 35 U.S.C. § 371 as a United StatesNational Phase Application of International Patent Application Ser. No.PCT/GB02/01690 filed Apr. 10, 2002, which claims priority from GreatBritain Application No. 0109001.8 filed in the United Kingdom on Apr.10, 2001.

The present invention relates to a device for dispensing apharmaceutical substance. In particular, the invention relates to adevice for dispensing a pharmaceutical substance by intranasaladministration.

European Patent Publication No. EP-A-0546607 in the name of Glaxo GroupLimited discloses a dispenser for manual discharge of a single dose of aflowable substance. The device consists of a casing with a nozzle memberand shoulders to the sides of the nozzle member. The nozzle member has apiston extending inwardly from an outlet opening, the piston having atleast one discharge channel. A vial of the pharmaceutical substance tobe dispensed is mounted on the piston member with a stopper arrangedacross the vial to seal in the substance. The piston includes a hollowneedle, so that on pressing of the vial onto the piston member, thestopper is pierced by the needle to allow the substance to be expelledthrough the discharge channel and out of the nozzle opening. Thedescribed device is a one-use only device and is intended to bediscarded after use.

International Patent Publication No. WO97/42992 in the name of GlaxoWellcome Australia Limited discloses a device for dispensing a unit doseof a pharmaceutical substance. The device includes a body member whichhas a discharge system which can be operated by the user to effectdischarge of the pharmaceutical substance, in particular by means of aspring loaded air piston which injects air into a container of thesubstance to discharge it. A number of nozzle assemblies are provided,each nozzle assembly including a container of a unit dose of thepharmaceutical substance. A single nozzle assembly is mounted on thebody member and in one embodiment a driving spring for the air piston isloaded with spring energy by the action of mounting the nozzle assemblyon the body. After the spring is released, and the substance thusdischarged, the nozzle assembly is discarded and a fresh nozzle assemblycan be mounted on the body as required.

U.S. patent Publication No. U.S. Pat. No. 5,137,516 again in the name ofGlaxo Group Limited describes a device for administering a dose of apharmaceutical substance, in particular by self-injection by the user.The device holds a syringe of the pharmaceutical substance and thesyringe is pressed against the user's skin by a spring force, the springforce being released by relative movement of cooperating sleeves of thedevice and by pressure on a button on one end of the device. The springcan be placed into a ready-to-use state by loading of the syringe ontothe device. The device may be provided in a carry case, along with asmall number of spare syringes.

There remains a need for a pharmaceutical dispensing device which iseasy and convenient to use.

According to the invention there is provided a device for dispensing apharmaceutical substance comprising:

a base member and a cover member closeable thereon;

a dispensing member which is movable between a first position on thebase member under the closed cover member and a second positionprotruding from the base member after opening and reclosing of the covermember;

a container of the pharmaceutical substance to be dispensed;

an actuating member for discharging the pharmaceutical substance fromthe container and through the dispensing member;

wherein in the second position of the dispensing member the container isin registration with the actuating member so that the release member cancause dispensing of the pharmaceutical substance through the dispensingmember.

Preferably, the dispensing member includes the container and thedispensing member is removable from the base member for disposal afteruse.

The dispensing member is preferably pivotable relative tithe basebetween the first and second position.

The dispensing member can have a protective cap which has locking wingsto hold it on the dispensing member, the locking wings being retractedupon mounting of the dispensing member on the base.

The base member preferably has an edge surface which preventsregistration of the dispensing member with the actuating member untilremoval of the protective cap.

The actuating member has a primed condition and an unprimed condition,and the primed condition can be achieved by sliding movement of acarriage on the base member.

The cover member advantageously cooperates with the carriage such thatafter dispensing, opening of the cover member slides back the carriageto its initial position.

A push button on the base or cover member can move the release member,inclined surfaces on the release member then moving catches on the basemember which hold the actuating member.

A preferred embodiment of the invention is described in more detailbelow, by example only, with reference to the accompanying drawings:

FIG. 1 is a perspective view of a device for dispensing a pharmaceuticalsubstance in accordance with an embodiment of the invention, in a closedcondition;

FIG. 2 is a perspective view of the device of FIG. 1 in an opencondition;

FIG. 3 is an exploded perspective view of the device of FIGS. 1 and 2,but omitting the unit which contains the pharmaceutical substance to bedispensed;

FIG. 3 a is a perspective view of a part of FIG. 3, but at a largerscale;

FIGS. 4 a and 4 b are perspective views of the unit which contains thepharmaceutical substance, FIG. 4 a being a partly exploded view;

FIGS. 5 a and 5 b are vertical and horizontal sectional views of thedevice, showing the unit containing the pharmaceutical substance in itsinner position;

FIGS. 6 a and 6 b are sectional views similar to those of FIGS. 5 a and5 b, but showing the unit containing the pharmaceutical substance in itsouter position, ready-to-use;

FIGS. 7 a and 7 b are similar sectional views, showing the device in aprimed condition;

FIGS. 8 a and 8 b are similar sectional views showing the device in aused condition, with the pharmaceutical substance having been dispensed;

FIGS. 9 a and 9 b are perspective views from above and from belowshowing in detail the operation of the release mechanism of the device;and

FIGS. 10 a to 10 e are detail sectional views showing the movement ofparts of the device as the base and cover are moved relative to oneanother.

The perspective view of FIG. 1 shows a device 1 for dispensing apharmaceutical substance, the device being in the form of a carry caseof a generally parallelepiped shape, the edges, ends and upper and lowersurfaces of the parallelepiped shape being rounded.

The carry case includes a base member 2 and a cover member 3, thesemembers being hingedly connected to one another at the lower end of thedevice as seen in FIG. 1. At the upper end of the device as seen in FIG.1, where the base 2 and cover 3 move apart from each other, an opening 4is provided in the end of the base, this opening 4 being closed by a lid5 which is mounted on the cover 3.

Lifting of the cover 3 from the base 2, and thus opening of the device,is achieved by squeezing together the sides of the cover 3.

The open condition of the device is shown in the perspective view ofFIG. 2. In this Figure it can be seen that the cover 3 is pivoted awayfrom the base 2. A unit 6 which contains the pharmaceutical substance tobe dispensed is mounted on a support 7 which in turn is pivotallymounted on the base 2. In this embodiment, where the pharmaceuticalsubstance is intended for nasal administration, the unit 6 is of agenerally cylindrical shape with dimensions appropriate for insertioninto the user's nasal cavity, after removal of a protective cover. Inview of its shape and function, the unit 6 which contains thepharmaceutical substance is referred to in the following description asa nozzle unit.

On the cover 3 are arranged spare nozzle units 8, each of these beingidentical to the nozzle unit 6 mounted on the base 2 by means of thesupport 7.

The lid 5 which closes the end opening 4 of the base 2 is seen at thebottom of FIG. 2. Lid 5 is arranged on the cover 3 by means of a pivotalmounting 9.

The means by which the cover is opened and closed, relative to the base,are visible in the perspective view of FIG. 2. Curved portions 10 extendfrom the sides of the cover 3 and locate in correspondingly shapedrecesses 11 in the sides of the base 2. A catch 12 on the curved portion10 locates in a catch recess 1 on the inside of the cover, immediatelyadjacent the recess 13. Upon closing of the cover on the base, due tothe inherent resilience of the material from which the cover is formed,the catch 12 locates in the catch recess 11. Opening of the cover 3 isachieved by squeezing together the sides of the cover, at the curvedportions 10, thus releasing the catch 12. The arrangement of the catchand catch recess is of course present on both sides of the device.

The construction of the base and the cover, and the component partsthereof, are clearly shown in the exploded perspective view of FIG. 3.This Figure does not, however, show the nozzle unit 6 or the sparenozzle unite 8. In FIG. 3, the cover 3 is shown separated and above thebase 2. The pivoting support unit 7 is seen to the left of base 2.Carriage 14 is also seen above the base 2, this carriage normally beingarranged on base 2 for sliding movement between a first, rearwardposition and a second, advanced position. Piston rod 15 is also normallymounted on the base, and this piston rod 15 can be driven by the forceof piston spring 16 to urge the pharmaceutical substance from the nozzleunit 6, upon actuation of the dispensing device.

The piston rod 15 is maintained in a non-dispensing position byresilient arms 17 on the inside of the base 2. Actuation of the device,and thus release of the piston rod 15, occurs by means of pressure on abutton 18 located in the base 2, button 18 cooperating with a shuttle19. Inclined surfaces 20 on the button 18 act on inclined surfaces 21 ofthe shuttle 19 to move the shuttle 19 along the base, this movementopening the arms 17 to release the piston rod 15, as will be describedin more detail below. The shuttle 19 moves against the action of shuttlespring 22.

The shuttle 19 is initially held against movement along the base by afirst safety catch 23 and a second safety catch 24. The purposes of thesafety catch catches are to ensure that the dispensing device isproperly and safely used. The full purpose of these safety features willbe described below.

The carriage 14 includes a blocking arm 25, which blocks forwardmovement of the carriage when a nozzle unit is mounted on the support 7and pivoted inside the device 1 (i.e. in the position seen in FIG. 2).The carriage 14 also includes piston rod housing 26 through which thepiston rod 15 extends. At each side of the carriage 14 is a catch arm 27at the forward end of which there is a hook catch 28. The catches 28engage over shoulders 29 on the base 2, when the carriage 14 is mountedin a rearward position on the base 2.

On each side of the carriage 14, adjacent the catch arms 27 there isarranged a cam track 30. A pin 31 at each inner side of the pivoting endof cover 3 moves around the cam track 30 in a manner to be describedbelow. The pivoting end of the cover 3 includes apertures 32 whichlocate over pivot lugs 33 on the base 2, to allow pivotal movement ofthe cover relative to the base 2.

Pivoting lugs 34 are provided on the support 7, these lugs 34 locatingin pivot apertures 35 at the forward end of the base 2. Thus, thesupport 7 can pivot about the base, between a position facing inwardlyof the base and a position facing outwardly of the base. In the outerposition the support 7 locates in the opening 4 of the base.

Cover spring 36 is fitted on the cover, to urge the lid 5 into aposition closing the opening 4 when the support 7 is folded inside thebase. When the support 7 is folded out of the base, obviously the lid 5cannot cover the opening 4 and in this situation, when the cover isclosed on the base, the lid 5 is folded back inside the cover, againstthe action of cover spring 36.

A plug 37 is provided to close the end of the passage through the pistonhousing 26 of the carriage 14. The end of the passage is not visible inFIG. 3, but it can be explained here that the piston rod 15 and pistonspring 16 are mounted in the carriage 14 by insertion through the outerend of the carriage, the opening in the carriage then being closed bythe plug 37.

An inner cover plate 38 is provided between the base 2 and the cover 3.The cover plate 38 is mounted on the base to conceal the operating partsof the actuating mechanism, in particular the shuttle 19, spring arms 17and inner surfaces of the button 18.

The support 7 is shown in more detail in the enlarged perspective viewof FIG. 3 a. The support 7 is shaped so as to snugly receive the nozzleunit 6. Correct mounting of the nozzle unit 6 is ensured by means of agroove 75 which curves around the inside of the support. Immediatelyadjacent the groove 75 are opposing inclined surfaces 76 which approacheach other as they extend into the support. The purpose of groove 75 andsurfaces 76 will be explained shortly.

FIGS. 4 a and 4 b show the nozzle unit 6 which in FIG. 2 is shownmounted on the pivoting support 7. The nozzle unit 6 includes a cap 40,a nozzle member 41 and a vial holder 43 which holds a vial of thepharmaceutical substance to be dispensed (the vial not being visible inthis Figure). At each side of the cap 40 are cap wings 44 and at the endof each wing there is a protruding part 45 which forms a cap wing catch.The nozzle member 41 has a skirt 46 extending laterally therefrom, theskirt having skirt legs 47 and skirt openings 48. The cap wings 44 areresilient and upon location of the cap 40 over the nozzle member 41 thecap wings 44 locate in the skirt openings 48, with the cap wing catches45 clipping under the skirt to prevent removal of the cap 40 from thenozzle member 41.

The skirt legs 47 include, on their inner surfaces, a circumferentialgroove 49. At the forward end of the nozzle member 41 there is a nozzleopening 50, through which the pharmaceutical substance is dispensedafter the nozzle member is inserted in the user's nasal cavity.

The skirt 46 has a rounded shape on one side which matches the curvedshape of the groove 75 of the support 7. This matching of shape ensuresthat the nozzle unit can only be inserted into the support in onepredetermined orientation. Upon insertion, the skirt 46 fits in thegroove 75 and the cap wings 44 will be forced along the surfaces 76which will tend to draw the cap wings 44 closer together.

The vial holder 43 is of a generally cylindrical shape and locateswithin the nozzle member 41. A circumferential rim 51 at the base of thevial holder 43 locates in the circumferential groove 49 of the skirtlegs 47 in order that the vial holder can be securely held within thenozzle member 41. The skirt legs have a degree of resiliency so that thevial holder can be pushed further within the nozzle member 41 by anappropriate force.

It can be mentioned at this point that the inner construction and theworking of the nozzle member is, in this embodiment, exactly asdescribed in European patent application number EP-A-0546607. Thus theway in which the pharmaceutical substance is held within the nozzlemember, and the way in which it is dispensed, need not be described indetail here. It can, however, be noted that the vial holder 43 in thepresent device is shorter than the equivalent member in EP-A-0546607. Inthe present case, it can be seen that the vial holder does not extendbeyond the ends of the skirt legs 47, so that accidental pressure on thevial holder 43, when the nozzle units are handled by the user, isavoided, the skirt legs 47 surrounding and protecting the end of thevial holder 43.

The vertical cross-sectional view of FIG. 5 a shows the device in aclosed condition, with the cover 3 closed onto the base 2, the lid 5closing the opening 4. The support 7 with a nozzle unit 6,mountedthereon is folded inside the device. As clearly seen in this Figure, theend of the blocking arm 25 of the carriage 14 is adjacent the end of thepivot unit 6, thus blocking movement of the carriage 14 along the base2. Piston rod 15 is seen mounted within the piston housing 26 of thecarriage, the end of the carriage housing 26 being closed by the plug37.

One side of the piston housing 26 has an open portion 54 into which oneend of the shuttle 19 can move, when the carriage is advanced. FIG. 5 ashows the shuttle catch 24 of the shuttle 19 located in a catch recess55 in the base 2, the holding of the catch 24 in the recess beingagainst the force of the inherent resiliency of the end portion of theshuttle 19. Accordingly, when the carriage is in such a position thatthe open portion 54 of the piston support 26 is next to the shuttlecatch 24, that catch can move out of the catch recess 55.

At the end of the shuttle 19 nearest to the opening 4 a lip 56 of theshuttle catch 23 locates over a shoulder 57 on the base 2. Upon rotatingof the support 7 together with the nozzle unit 6 out of the case, andupon removal of the cap 40, the shuttle catch 23 is pressed down solifting the lip 57 away from the shoulder 56. This is described in moredetail below with reference to FIG. 6 a.

In the sectional view of FIG. 5 a are also seen the internal componentparts of the nozzle unit 6. As described in more detail in EP-A-0546607there is a piston member 71 in which is mounted a hollow needle 72. Heldwithin the vial holder 43 is a vial 73 closed by a rubber stopper 74.The hollow needle 72 is in alignment with the nozzle opening 50. Upondepression of the vial holder 43, the needle 72 pierces the rubberstopper 74 and the stopper is pushed along the vial 73 by the pistonmember 71, thus expelling all of the contents through the needle andthus through the nozzle opening.

The horizontal sectional view of FIG. 5 b shows more clearly themounting of the carriage 14 and piston member 15 on the base 2. Asalready mentioned, the carriage 14 can slide along the base from therearward position shown in FIG. 5 b to a forward position. In therearward position the hook catches 28 of the arms 27 of the carriage 14locate over the shoulders 29 of the base. It will be noted that similarshoulders 68 are provided on the inside of the cover 3, in a moreforward position relative to the carriage, and when the cover is closedon the base of the shoulders 68 provide an advanced position for thecatches 28 (these shoulders 68 of the cover can also be seen in FIG. 2).

The piston member 15 is mounted on the carriage 14 through pistonhousing 26. At the rearward end of the piston there are two annularshoulders 61 and 62. Piston spring 16 is located against the shoulder61, the other end of the spring being located against the inner end ofthe plug 37 which is force fitted into the rearward end of the carriage.The other, more forward shoulder 62 abuts an annular lip 63 of thecarriage housing 26, thus preventing the piston member from movingfurther out of the housing 26.

FIG. 5 b also shows in more detail the blocking of the piston rod 15 bythe resilient arms 17 which are mounted on the base 2. At their rearwardends, the spring arms 17 have lugs 64 which engage against an annularshoulder 65 of the piston rod 15. Rounded portions 66 on the inside ofthe spring leg 17 rest against inclined surfaces 67 of the shuttle 19.The cooperation of the shuttle 19 and spring arms 17 will be describedin more detail below, but it is evident from FIG. 5 b that the pistonrod 15 cannot move to a more forward position until such time as theresilient arms 17 are opened.

The sectional views of FIGS. 6 a and 6 b are similar to those of FIGS. 5a and 5 b, but these Figures show the device in a ready-to-use state.The nozzle member 41 is positioned outside of the device so that it canbe inserted into the user's nasal cavity. To arrive at this position,the cover 3 must be opened and the nozzle unit 6 pivoted outwardly onthe support 7. After pivoting out of the nozzle unit, the cap 40 isremoved and the cover 3 is closed again. The closing action of the coverforces the lid 5 against the support 7 and the lid 5 is pivoted insidethe cover 3, against the action of the lid spring 36. In the outwardposition of the nozzle member 41 the outer end of the vial holder 43 isimmediately adjacent the forward end of the piston member 15. The nozzlemember is firmly held in place on the support 7 by the edges of theopening 4 of the base.

Upon previous mounting of the nozzle unit on the support 7 the inclinedsurfaces 76 on the inside of the support 7 have acted against the capwings 44, thus moving the cap wing catches 45 into a position at whichthey can move through the skirt openings 48 of the nozzle member 41. Inother words, correct mounting of the nozzle unit 6 on the support 7automatically releases the locking engagement of the cap 40 on thenozzle member 41. Thus, the cap 40 can easily be removed from the nozzleunit 6 when the nozzle unit is pivoted away from the base. Until suchtime as the cap 40 is removed, the nozzle member 41 cannot be moved tothe position shown in FIG. 6 a, in alignment with the piston rod 15,because the cap 40 is wider than the nozzle member 41 and would abut theedge of the opening 4. Equally, until the cap 40 is removed the cover 3cannot close on the base 2, as the nozzle unit would be blocking thefinal engagement of the cover on the base.

It will be seen from FIG. 6 a that when the nozzle member 41 iscorrectly positioned, pivoted outwardly of the base, then the shuttlecatch 23 locates in the gaps between the skirt arms 47 of the nozzlemember 41, thus allowing the vial holder 43 to press the catch 23. Theshuttle catch 23 is arranged at the end of the shuttle 19 on a “livinghinge” and a force on the inclined surface of the shuttle catch 23 actsto pivot the lip 56 off the shoulder 57 of the base 2. It can be notedat this stage that if an already used nozzle member were mounted, thenthe vial holder 43 would be at an advanced position within the nozzlemember 41 and could not, therefore, contact the shuttle catch 23 torelease it.

To bring the device shown in FIGS. 6 a and 6 b into an actuationcondition, it is necessary to advance the carriage 14 along the base 2.This is done by the user pushing the carriage 14 into the device, forexample by means of thumb pressure on the surface of the plug 37.

The advanced position of the carriage 4 is shown in FIGS. 7 a and 7 b.From FIG. 7 b, it can be appreciated that carriage 14 is advanced to aforward position in which the carriage hooks 28 engage over theshoulders 68 on the inside of the cover 3. The carriage arms 27 have asufficient degree of resiliency to allow the hooks 28 to pass theshoulders 68, before snapping outwardly to engage over the shoulders 68.

As the piston member 15 remains blocked by the resilient arms 17 on thebase 2, on the advancement of the carriage 14, the piston housing 26moves along the piston member 15 and the piston spring 16 is compressedbetween annular shoulder 61 of the piston member 15 and the inside ofthe plug 37. In the advanced position of the carriage 14, the openportion 54 of the piston housing 26 registers with the catch 24 of theshuttle 19, thus allowing the catch 24 to disengage from the catch hole55 in the base 2.

In the condition seen in FIGS. 7 a and 7 b, both safety catches 23 and24 of the shuttle 19 are released from the base 2, leaving the shuttle19 in a condition in which it is able to move along the base 2, againstthe action of shuttle spring 22.

FIGS. 8 a and 8 b show the condition of the device wherein the button 18has been depressed, the resilient arms 17 opened and thus the piston rod15 released. The cooperation of the button 18 with the shuttle 19 andthe resilient arms 17 is described in detail below with reference toFIGS. 9 a and 9 b.

Upon opening of the resilient arms 17, the lugs 64 move away from theshoulder 65 of the piston rod is. As soon as the resilient arms 17 areclear of the piston rod 15, the force of the piston spring 16 urges thepiston rod 15 forwardly, immediately pushing the vial holder 43 into thenozzle member 41. In the same way in which the pharmaceutical substanceis dispensed in prior application EP-A-0546607, movement of the vialholder 43 within the nozzle member 41 in the present device causes thecontained pharmaceutical substance to be sprayed out of the nozzleopening 50 into the user's nasal cavity.

Of course, for delivery of the pharmaceutical substance, the user placesthe device in such a position that the nozzle member 41 is in one of thenasal cavities, the device being held in the hand with the thumb overthe button 18.

Upon release of the button 18 (i.e. when the button moves to the left inFIG. 8 a) the shuttle spring 22 will move the shuttle 19 in a forwarddirection so that the shuttle catch 23 is again engaged with the base 2.It is seen from FIG. 8 a that with the vial holder 43 advanced withinthe nozzle member 41 the shuttle catch 23 is allowed to assume itsposition engaged behind the shoulder 57 of base 2.

As indicated above, FIGS. 9 a and 9 b show the cooperation between thebutton 18, the shuttle 19 and the arms 17 of the base 2. The perspectiveviews of FIGS. 9 a and 9 b are from opposite sides, so that both top andbottom surfaces of the relevant parts can be seen.

Button 18 is of a generally circular configuration and is clipped into acorrespondingly shaped aperture in base 2. On the inside surface of thebutton 18 there are two sets of two inclined surfaces 20 which are forsliding engagement with correspondingly inclined surfaces 21 on theshuttle 19. The surfaces 21 are formed on integrally moulded blocks 80,81 along the length of the shuttle 19. The block 81 nearest to shuttlecatch 24 includes the lateral inclined surfaces 67 which are bevelledoutwardly, away from the shuttle catch 24 end.

Between this block 81 and the shuttle catch 24 is formed a rectangularopening 83 including a pin 84 for location of the shuttle spring 22. Onassembly of the shuttle 19 to the base 21 the rectangular 83 openingfits over an internal lip 85 of the base 2 (see. FIG. 5 a for example),with the shuttle spring 22 abutting against the lip 85.

Upon movement of the button upwardly as seen in FIG. 9 a, or downwardlyas seen in FIG. 9 b, the inclined surfaces 20 of the button move againstthe correspondingly inclined surfaces 21 of the shuttle 19, thus forcingthe shuttle to the right in FIG. 9 a, i.e. rearwardly in the device.This movement in turn pushes the lateral inclined surfaces of the blockof the shuttle 19 along the rounded portions 66 of the resilient arms17, forcing the arms 17 to open and releasing the lugs 64 from theshoulder 65 of the piston arm is.

FIGS. 9 a and 9 b clearly show the safety catch 23, including the livinghinge 86 connecting the catch to the shuttle 19.

After actuation of the device, the used nozzle member 41 will need to bedisposed of. To remove the nozzle member, the cover 3 is opened, thesupport 7 pivoted back inside the base 2 and the used nozzle member 41removed for safe disposal.

FIGS. 10 a to 10 e show how the opening of the cover 3 retracts thecarriage 14 to its rearward position. As briefly mentioned in relationto FIG. 3, a pin 31 on each side of the pivoting end of the cover 3cooperates with a cam track 30 on the sides of the carriage 14. At thebase side of the track, there is a straight portion 90 which is parallelto the direction of movement of the carriage 14 along the base 2. At theforward end of this straight portion there is an arcuate portion 91extending back around approximately 180°. From the rearward end of thestraight portion a slightly curved portion 92 extends to intersect thearcuate portion 91 approximately ¾ of the way along its length from theforward end of the straight portion 90.

FIG. 10 a shows the cover closed 3 on the base 2, with the carriage 14in its normal, rearward position. Here the pin 31 is located at theforward end of the straight portion 90 of the track 30. It is clear thatupon opening and closing of the cover 3, the pivotal movement of thecover will move the pin 31 along the arcuate portion 91. With 180°opening of the cover 3, the pin 31 will of course arrive at the oppositeend of the arcuate track 91.

FIG. 10 b shows the carriage 4 in its advanced position, i.e. in aposition shown in FIGS. 7 a and 7 b. With the forward movement of thecarriage 14 along the base 2, the pin 31 moves relative to the carriage14 such that it is located at the rearward end of the straight portion90 of the track. After actuation of the device and opening of the cover3, it is seen in FIG. 10 c that the pin is forced along the inclinedportion 92 which acts as a cam surface. Thus, pivoting of the cover 3forces the pin to retract the carriage 14.

The retracted position of the carriage is seen in FIG. 10 d. Forcompleteness, it is noted at this point that opening of the coverdisengages the shoulders 68 of the cover from the hooks 28 of thecarriage, freeing the carriage to move back to its initial position.Upon full retraction of the carriage 14 the pin 31 is able to move tothe end of the arcuate portion 91 of the track, should full 180° openingof the cover be desired by the user. This condition is seen in FIG. 10e.

Whether the cover 3 is moved back to the closed position from the stateseen in FIG. 10 d or the state seen in FIG. 10 e, it will be understoodthat upon pivoting of the cover 3 relative to the base 2 the pin 31 willtravel back around the arcuate portion 91 of the cam track 30 to theposition shown in FIG. 10 a. In this condition, the cover 3 is closedand the carriage 14 is again in its rearward position.

Having described the construction of the device for administering apharmaceutical substance in accordance with this embodiment of theinvention, the way the device is intended to be used will now bedescribed (though many of the aspects of the operation of the devicewill already have been understood from the above description of thedevice and the interaction of the different parts thereof).

In the normal situation, the user will start with a closed device, withan unused nozzle unit 6 mounted on the support 7 and folded onto thebase 2 with the cover 3 folded down thereover. In other words, in thenormal start condition the device will be in the condition seen, inFIGS. 1 and 5.

If it is assumed that the pharmaceutical substance contained in thenozzle unit is Sumatriptan then the device will be used for thealleviation of the symptoms of a migraine. On sensing the onset of amigraine attack, the user will lift the cover 3 of the device and foldout the nozzle unit 6. Previous mounting of the nozzle unit on thesupport 7 will have disengaged the catches on the cap 40 of the nozzleunit 6. Thus, the user can easily remove the cap 40 so that the nozzlemember is ready for location in the nasal cavity. After removal of thecap 40, the cover 3 is closed back onto the base 2. If the support, 7has not already be pivoted out to its full extent, the closure of thecover 3 on the base 2 will complete the movement of the support 7, andthus the nozzle member 41, so that the nozzle member 41 is correctlyaligned with the piston rod 15. This condition is seen in FIGS. 6 a and6 b.

As already mentioned above, pivoting of the nozzle unit out to its fullextent releases the forward catch 23 of the shuttle 19. In thisposition, the device is ready to be brought into an actuation conditionby the user. To achieve this, and thus to cock the spring 16 whichdrives the piston rod 15, the user presses the carriage 14 into thedevice, thus forcing the carriage 14 to slide along the base in adirection towards the nozzle unit. As the piston rod 15 is blocked bythe spring arms 17, the piston housing 26 of the carriage 14 slidesrelative to the piston rod 15, thus compressing the piston spring 16. Inthe advanced position of the carriage 14, the catches 28 on the carriagearms 27 locate over the forward shoulders 68 of the cover 3. With thecarriage in the advanced position, the rearward catch 24 of the shuttle19 has disengaged from the base 2. This position of the carriage is seenmost clearly in FIG. 7 b.

The device is now ready to be operated by the user in order to deliver apredetermined dose of the pharmaceutical substance. The device is heldin the user's hand, with the nozzle member correctly located in thenasal cavity and the button 18 is depressed. Depression of the button 18forces the shuttle 19 to slide in a rearward direction, the lateralinclined surfaces 67 of the shuttle 19 opening the arms 17 of the base.With the arms 17 separated, the piston rod 15 is released so that underthe force of the spring 16 it drives the vial holder 43 into the nozzlemember 41. Thus, the pharmaceutical substance is delivered to the user,in the same manner as described in prior application EP-A-0546607.

With the spring 16 having a predetermined resilient force, the pistonrod 15 will be driven with a predetermined and relatively constantforce, so that a very reliable expulsion of the substance out of thenozzle opening 50 will be achieved. The condition of the device with thepiston rod released and the substance dispensed is shown in FIGS. 8 aand 8 b.

At this stage the actions of any individual user cannot be predicted, inthat if someone is suffering from a severe migraine attack they may atthis point simply put the device down and only deal with it when theattack is over, or at least the symptoms have been greatly alleviated.However, after actuation, the user will ideally open the cover, fold inthe used nozzle member 41 and remove that nozzle member for disposal.The cover can of course be closed again at this point, but it ispreferable for a replacement nozzle unit 6 to be located in the support7, so that the device will be immediately ready for use at a later date.A spare nozzle unit will be present on the inside of the cover 3 andthat spare unit can itself be replaced by another unit.

As discussed in particular in relation to FIGS. 10 a to 10 e, theopening of the cover 3, after administration of the pharmaceuticalsubstance, automatically brings the carriage 14 back to its rearwardposition. Thus, on mounting a replacement nozzle unit and again closingthe cover, the device is again in a ready-to-use condition, as seen inFIGS. 5 a and 5 b. It is thus understood that the device is easy to useand can be operated in a reliable and straightforward fashion to quicklyand efficiently dispense a dose of pharmaceutical substance, as the needarises.

It will also be appreciated that the device includes several securityfeatures to ensure that the device is operated in the intended fashion.In particular, the following features are included.

-   -   1. The cover joins with the base by means of a child proof        closure. Only by applying inward pressure to the sides of the        cover at the appropriate point can the device be opened.    -   2. The cap of the nozzle unit can only easily be removed upon        mounting of the nozzle unit on the support. Thus, the cap        protects the nozzle itself from contamination, prior to use (the        pharmaceutical itself, inside the nozzle member, is sealed        inside the vial, until such time as the stopper is punctured by        the needle). The cap also acts as a tamper evident feature, so        that the user can immediately see if a nozzle member has already        been used. In other words, the user will only try and administer        the pharmaceutical substance from a nozzle unit which has a cap        correctly in place.    -   3. The cap cannot be removed from the nozzle unit until the        support is pivoted to the outward position. Thus, the cap cannot        be inadvertently removed after initial mounting of the nozzle        unit on the support with the support still folded inwardly of        the base.    -   4. The piston spring cannot be cocked until the device is in a        ready-to-use condition. In particular, until the nozzle unit is        pivoted out, the carriage is blocked by the nozzle unit mounted        on the support. Similarly, there is no possibility of cocking        the spring when the case is open as the carriage cannot be        engaged in a forward position until the shoulders 68 of the        cover are adjacent the base.    -   5. The cover cannot be closed onto base until the cap is removed        from the nozzle unit which has already been pivoted out from the        base. Thus, there is no possibility of the user trying to        administer the pharmaceutical substance without first removing        the cap from the nozzle member.    -   6. Only with the cap removed from the nozzle unit can the nozzle        member be fully pivoted out from the base and only in the fully        pivoted position will the vial holder release the forward catch        of the shuttle. Thus, the shuttle is locked against movement        until a nozzle unit with the cap removed is pivoted out.    -   7. If the user tries to activate the device with an already used        nozzle member, then the vial holder will be in such a forward        position that it does not release the catch of the shuttle.        Thus, the user cannot reuse a nozzle member. Similarly, if no        nozzle member at all is present the shuttle catch remains locked        against the base.    -   8. The rearward shuttle catch remains locked against the base        until such time as the carriage is in its forward position. This        prevents the piston rod from being released by pressure on the        button until such time as the piston spring is properly        compressed. Thus, reliable dispensing of the pharmaceutical        substance within the nozzle member is ensured.    -   9. The nozzle units themselves are protected against accidental        actuation by virtue of the fact that the skirt legs of the        nozzle member surround the vial holder, so that upon handling of        the nozzle unit the vial holder is not accidentally pushed into        the nozzle member by the user's fingers or thumb.

The component parts of the device described above are moulded from asuitable plastics material. For example, the base, cover and support canbe made of ABS (Acrylonitrile Butadiene Styrene) or polycarbonate (PC).The carriage, button and plug can similarly be made of PC, while thepiston and shuttle might be made of polyoxymethylene (POM). The springsare made of steel.

1. A device for dispensing a pharmaceutical substance comprising: a basemember and a cover member closeable thereon; a dispensing member whichis movable between a first position on the base member under the closedcover member and a second position protruding from the base member afteropening and redo sing of the cover member; a container of thepharmaceutical substance to be dispensed; and an actuating member fordischarging the pharmaceutical substance from the container and throughthe dispensing member; wherein in the first position of the dispensingmember the container is not in registration with the actuating member sothat a release member can cause dispensing of the pharmaceuticalsubstance through the dispensing member; and wherein in the secondposition of the dispensing member the container is in registration withthe actuating member so that the release member can cause dispensing ofthe pharmaceutical substance through the dispensing member.
 2. A deviceaccording to claim 1, wherein the dispensing member is pivotablerelative to the base between the first and second position.
 3. A deviceaccording to claim 2, wherein the dispensing member is mounted on asupport which is pivotally connected to the base.
 4. A device accordingto claim 3, wherein the dispensing member has a protective cap which haslocking wings to hold it on the dispensing member, the pivotal supporthaving surfaces which retract the locking wings upon mounting of thedispensing member on the support.
 5. A device according to claim 4,wherein the base member has an edge surface which prevents registrationof the dispensing member with the actuating member until removal of theprotective cap.
 6. A device according to claim 3, wherein the dispensingmember is slidable onto and off of the pivotal support.
 7. A deviceaccording to claim 1, wherein the actuating member has a primedcondition and an unprimed condition, the primed condition being achievedby sliding movement of a carriage on the base member.
 8. A deviceaccording to claim 7, wherein the cover member cooperates with thecarriage such that after dispensing, opening of the cover member slidesback the carnage to its initial position.
 9. A device according to claim8, wherein a pin on the cover cooperates with a cam track on thecarriage.
 10. A device according to claim 7, wherein the carriageincludes a surface which is blocked by the dispensing member in itsfirst position, thus preventing movement of the carriage.
 11. A deviceaccording to claim 10, wherein the surface is at the end of an arm ofthe carriage.
 12. A device according to claim 7, wherein the carriageand dispensing member are provided at opposite ends of the base member,the carriage being slidable in a direction towards the dispensing memberin its second position, the actuating member comprising a piston rodarranged between the carriage and the dispending member.
 13. A deviceaccording to claim 12, wherein the release member is elongate and isarranged on the base parallel to the piston rod, the safety catches ofthe release member being at opposite ends thereof and the push buttonbeing moveable perpendicularly to the release member.
 14. A deviceaccording to claim 7, wherein sliding of the carriage compresses aspring which is released by the release member to actuate the actuatingmember.
 15. A device according to claim 7, wherein the safety member hasa second safety catch which holds it in position on the base, the secondsafety catch being released upon sliding movement of the carriage.
 16. Adevice according to claim 7, wherein the carriage can be held in aforward condition on the base by means of catch surfaces on the cover.17. A device according to claim 1, wherein the dispensing member isremovable from the base member for disposal after use.
 18. A deviceaccording to claim 17, wherein two or more spare dispensing members aremounted on the base or cover member.
 19. A device according to claim 1,wherein a push button on the base or cover member is configured to movethe release member, with inclined surfaces on the release member beingconfigured to move catches on the base member which hold the actuatingmember.
 20. A device according to claim 19, wherein the catches of thebase member are at the ends of resilient arms.
 21. A device according toclaim 1, wherein the dispensing member includes the container.
 22. Adevice according to claim 1, wherein the release member has at least afirst safety catch which holds it in position on the base, the firstsafety catch being released by movement of the dispensing member to thesecond position.
 23. A device according to claim 1, wherein thedispensing member is nozzle shaped for insertion in a nasal cavity.